Copyright © 2009 AOAC INTERNATIONAL. All Rights Reserved.
Comments, Questions, Concerns, e-mail webmaster@aoac.org.
The Analytical Community—Key to Generating Methods
The focus in AOAC has shifted from the individual chemist or lab to “communities” as the primary source for new methods.
This page defines the community, the Dietary Supplements community, and what it can do for you:
It is a group of like-minded individuals, organizations, companies, and agencies with common analytical needs. In the words of Anita Mishra, AOAC Principal Scientific Liaison, Government and Industry, a community comprises “stakeholders from government, industry, trades, and academia in a specific scientific area who ‘associate’ to develop fit-for-purpose, validated methods and services for assuring quality measurements.” A community’s goal is to locate methods needed in their shared realm of expertise and to set priorities for validation by AOAC.
Since AOAC’s founding in 1894 for the purpose of establishing reliable analytical results on fertilizers, to today’s broad-based involvement in analytical and microbiological testing, the aim continues to be creating methods that can be reliably applied in qualified labs anywhere.
AOAC now obtains financial support from fees for validating methods rather than sales of the publication. Grants from federal agencies, which had dried up, are now returning in larger and larger amounts. An important portion of the new financial support has come from quality control of dietary supplements. Methods for quick detection and monitoring of pathogens and toxins arising from the Bioterrorism Act is a major source of revenue.
Creation of analytical communities has come about as a means to focus on methods most urgently needed by large segments of commerce and regulation. A “community” may be defined by a common subject matter (dietary supplements), a common matrix (botanicals), or a common analyte (aristolochic acid). Some are very broad in scope, some very focused. The AOAC supplies intellectual power and expertise to develop and validate methods that are, in turn, needed by agencies and organizations with the money to pay for the validation—mutual support that keeps methods flowing to where they are needed.
Methods flow from the communities to AOAC for validation, and communities are becoming sources for funding as they tap industry and organizations for support. If a group or company (manufacturer) outside the communities wants a method validated (for a proprietary test kit, for example), they pay fees to have AOAC perform the validation. These fees are now a major source of support.
As of end 2008, AOAC had formed or proposed a number of communities:
AOAC Past-President described a revolutionary vision of a community: “a team and shared vision that sacrifices ego for the common good, but with opportunities for individual contribution and recognition. A community, properly led, captures the spirit and imagination of its members.”
What is the Dietary Supplements Community?
All parties who must analyze dietary supplements, use the analytical esults, label products to comply with the FDA regulations, regulate those products, or compare products. A community may include manufacturers, trade organizations, regulators, laboratories, consumer groups, and academics. AOAC brings these interested parties together to discuss, choose, evaluate, and validate methods of analysis for dietary supplements. Task groups meet to identify areas where methods are mostly critically needed, locate methods, and get them validated.
No. Groups who certify products, such as NSF International, carry out tests to:
In short, NSF (or other product certification groups) would use validated analytical methods to carry out their tests. AOAC is in the business of finding, validating, and distributing these methods to labs who need them.
“Validation” speaks for itself; it’s a process where an analytical method is demonstrated to produce reliable analytical results in the hands of a qualified laboratory staff. Members of the Presidential Task Force on Dietary Supplements, representing the broad range of interests in analytical testing, meet and select methods for validation, based on need and availability of methods for testing. Panels of experts on the method (also volunteers) review methods, and Task Force members search for labs and samples to use in testing the method. Volunteer labs—who themselves need the validated methods—test well-characterized actual samples under protocols that allow rigorous statistical analysis of the data. Those methods which pass the standards for reliable testing become available for use by anyone needing the method for the specific supplement or botanical.
Validation may demonstrate reliability for use within a single lab—that is, for the personnel in the lab that tests it—or it may go to a higher level and undergo “collaborative testing,” where samples are distributed to many labs and their results subjected to statistical analysis. Methods that prove reliable enough to produce good results in any qualified lab are the Gold Standard of testing, those published as AOAC Official Methods of Analysis.
Why Do I Need Validated Methods?
You might be using methods in your own lab to determine the active ingredients and check for adulteration or contamination. If you are the only lab using that method, the numbers on your label can’t be compared to other products. A company using another method, which may produce more apparently favorable numbers, might have a competitive advantage. Only if all labels are produced using the same methods, validated for reliability, will the community have a level playing field—with numbers that can be compared to one another. Consumers will choose based on fact rather than on illusions produced by methods that may or may not be reliable. Competition will be fair and based on science-based numbers on the labels.
Join the AOACI Dietary Supplements Community. Come to Task Force meetings to discuss the methods you need and how to start the process to produce them. We need laboratories for validation studies, we need well-characterized samples to test methods—and we need methods. You are the source for all those; join us, and you can help produce reliable validated methods for your dietary supplement products. For more ideas, see "Get Involved".
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| Copyright © 2009 AOAC INTERNATIONAL. All Rights Reserved. Comments, Questions, Concerns, e-mail webmaster@aoac.org. |